Annovis Bio and AbbVie have recently announced significant advancements in their respective clinical programs targeting neurodegenerative diseases. Annovis Bio has commenced a pivotal Phase 3 trial for buntanetap in early Alzheimer's disease, while AbbVie reported positive topline results from a Phase 3 trial of tavapadon for early Parkinson's disease.
Annovis Bio's Buntanetap Enters Pivotal Phase 3 Trial for Early Alzheimer's Disease
Annovis Bio Inc. (NYSE: ANVS) has announced the enrollment of the first patients in its Phase 3 study evaluating buntanetap for early Alzheimer's disease (AD). This randomized, placebo-controlled, double-blind study is designed to assess the safety and efficacy of a daily dose of buntanetap over 18 months. The trial includes a 6-month assessment of symptomatic effects followed by a 12-month evaluation of the drug's potential disease-modifying effects.
"The launch of our highly anticipated AD study is a significant milestone in advancing buntanetap toward market approval and addressing the unmet medical need of millions of patients," said Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis. "Our previous trials have delivered compelling results, and we have meticulously designed a comprehensive protocol to evaluate both the symptomatic and potential disease-modifying effects of our drug candidate."
The Phase 3 protocol received FDA approval based on positive data from a previous Phase 2/3 trial, which demonstrated significant cognitive improvement in a subgroup of patients with early AD and showed no safety concerns. The company has secured $21 million in funding for the initial 6-month portion of the study and anticipates enrolling over 750 participants across approximately 100 sites in the United States. The primary outcomes will include assessing cognition using the Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog13) subscale and functional ability using the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) scale.
Buntanetap is a small, orally available molecule that targets neurodegeneration by inhibiting the translation of neurotoxic aggregating proteins, improving axonal transport, synaptic transmission, and reducing neuroinflammation. By normalizing these pathways, buntanetap has the potential to reverse neurodegeneration and improve the quality of life for patients.
AbbVie's Tavapadon Shows Promise in Phase 3 Trial for Early Parkinson's Disease
AbbVie (NYSE: ABBV) has announced positive topline results from its Phase 3 TEMPO-2 trial evaluating investigational tavapadon as a flexible-dose monotherapy in early Parkinson's disease. Tavapadon is the first and only D1/D5 partial agonist under investigation as a once-daily treatment for Parkinson's disease.
The TEMPO-2 trial evaluated the efficacy, safety, and tolerability of a flexible-dose (5 mg to 15 mg, once daily) treatment with tavapadon as a monotherapy in adults with early Parkinson's disease. The trial met its primary endpoint, with patients treated with tavapadon experiencing a statistically significant reduction (improvement) from baseline compared to placebo (placebo: -1.2; tavapadon 5-15 mg: -10.3; p-value <0.0001 versus placebo) in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score at week 26.
The TEMPO-2 trial also met the key secondary endpoint, demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living (MDS-UPDRS Part II) in the tavapadon group (5-15 mg) compared to placebo at week 26.1
"The positive results across all three Phase 3 TEMPO trials underscore the potential of tavapadon as a first-in-class D1/D5 partial agonist for the treatment of Parkinson's disease," said Primal Kaur, M.D., MBA, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie. "With these data in hand, we look forward to working with regulatory agencies to assess next steps, bringing us one step closer to providing tavapadon for those living with this chronic, debilitating disease."
AbbVie plans to submit a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in 2025. The TEMPO clinical development program evaluated the efficacy, safety, and tolerability of tavapadon across a broad Parkinson's disease population, including two monotherapy Phase 3 trials (TEMPO-1 and TEMPO-2) and one adjunctive Phase 3 trial (TEMPO-3).
